Kornimate/medical-research-clean huggingface dataset:
study evaluating the pharmacokinetics (pk) and safety of bosutinib in subjects with liver disease and in healthy subjects

Conditions: Breast Cancer; Leukemia, Myeloid, Chronic

Summary: the purpose of this study is to assess the pharmacokinetics of bosutinib and the safety and tolerability of bosutinib in healthy subjects and subjects with liver disease.


Eligibility criteria:
inclusion criteria (for both study populations): 1. men or women of nonchildbearing potential (woncbp) aged 18 to 65 years inclusive at screening. woncbp may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for more than 1 year (with follicle-stimulating hormone \[fsh\] level greater than or equal to 8 miu/ml) and must have a negative serum pregnancy test result within 48 hours before administration of test article. women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound scan. sexually active men must agree to use a medically acceptable form of contraception during the study and continue using it for 12 weeks after test article administration. 2. have a high probability for compliance with and completion of the study. exclusion criteria (for both study populations): 1. history of clinically important cardiovascular disease. 2. family history of qt prolongation, syncope, seizure, or unexplained cardiac-related death. 3. presence or history of any disorder that may prevent the successful completion of the study. other inclusion and exclusion criteria apply.
additive effects of pravastatin and valsartan

Conditions: Hypertension; High Cholesterol

Summary: the investigators hypothesize that pravastatin combined with valsartan may have additive effects in hypertensive, hypercholesterolemic patients.


Eligibility criteria:
inclusion criteria: * hypertension and low-density lipoprotein cholesterol levels \>100 exclusion criteria: * overt liver disease chronic renal failure hypothyroidism myopathy uncontrolled diabetes severe hypertension

Keywords: insulin resistance hypertensive hypercholesterolemic patients
effect of pelvic floor muscle training in stroke

Conditions: Stroke; Urinary Incontinence

Summary: aim: to evaluate the long term effect of pelvic floor muscle training in women with urinary incontinence after ischemic stroke measured by quality of life paramters.


Eligibility criteria:
inclusion criteria: * female stroke patients * one month since stroke * ui in close relation to the stroke * normal cognitive level * independent walking indoor ability \> 100 m * independence in toilet visit exclusion criteria: * urinary ineffections * vaginal prolabs * qronical lung disease * psychiatric diseases * other neurological diseases * do not speak danish

Keywords: physiotherapy stroke urinary incontinence quality of life
characteristics of lower respiratory tract escherichia coli isolates in mechanically ventilated intensive care patients

Conditions: Nosocomial Pneumonia; Ventilator Associated Pneumonia; Escherichia Coli Infections; Escherichia Coli Pneumonia; Escherichia Coli; Diarrhea, Enteroaggregative; Mechanical Ventilation Complication

Summary: prospective, multicenter observational study to collect escherichia coli (e. coli) isolates originating from mechanically ventilated intensive care unit (icu) patients; in order to characterize phenotype and genotype of e. coli strains retrieved from the lower respiratory tract of ventilated patients.

prospective, observational, multiple center study performed in 14 icus in france to collect escherichia coli (e. coli) isolates originating from mechanically ventilated intensive care unit (icu) patients; in order to characterize phenotype and genotype of e. coli strains retrieved from the lower respiratory tract of ventilated patients. all e. coli isolates identified in the microbiology lab and retrieved from a lung specimen (either tracheal aspirate, bronchoalveolar lavage, or telescopic plugged catheter) originating from an icu patient will be kept, and stored at -80°c in brain-heart infusion broth containing glycerol 20 %. they will be then centralized in the investigators' research unit for further analysis that includes determination of antimicrobial susceptibility, e. coli phylotype , o-type, and virulence factor gene content. these isolates will be compared to those of two previously published collections, one from the stools of community subjects, considered as commensal strains, the other from the blood of bacteraemia patients.

Eligibility criteria:
inclusion criteria: * adult, admitted to the intensive care unit * under invasive mechanical ventilation * presence of escherichia coli in lower respiratory tract specimen exclusion criteria: -

Keywords: virulence factor genes; phenotyping genotyping antimicrobial susceptibility
multiple interactive with nutrition and exercise strategies in frailty cancer patients

Conditions: Cancer

Summary: due to the changes in lifestyle caused by the covid-19, it is a priority to provide multi-interactive digital platforms and social media for nutrition and exercise programs for cancer patients. a two-year serial program uses mixed study methods of longitudinal combined experimental study. we will investigate cancer frailty's current situation and track the frailty trends after cancer patients received different treatments. we will also invite experts to develop multi-interactive digital platforms of nutrition and performance-based tailored circuit training programs according to the cancer frailty survey. we will recruit 20-85 years of newly diagnosed or first-time recurrence cancer patients and stratified randomization assigned to evaluate nutrition and physical exercise intervention effectiveness. the measure indicators were treatment-related adverse events, nutritional status, frailty status, survival rate, and life quality.


Eligibility criteria:
inclusion criteria: * aged from 20-85 years with histological confirmation malignancy. * requiring treatment by surgery, chemotherapy, hormonotherapy, radiotherapy, or targeted therapy with a curative intention as estimated by oncologists. * first diagnosed or recurrence of head and neck cancer, esophageal cancer, colon/rectum cancer, lung cancer, aml, all, lymphoma, multiple myeloma. exclusion criteria: * non-head and neck cancer, esophageal cancer, colon/rectum cancer, lung cancer, aml, all, lymphoma, multiple myeloma with first diagnosis or recurrence patients. * eastern cooperative oncology group test score\>2. * serious psychiatric or cognitive problems, and functional disability leading to a total inability to walk.
c677t methylenetetrahydrofolate reductase mutation

Conditions: Mutation

Summary: to investigate the effect of anticoagulant treatment on pregnancy outcomes in patients with previous recurrent miscarriages (rm) who carry a methylenetetrahydrofolate reductase (mthfr) gene mutation. in this longitudinal retrospective study, patients with rm were treated during pregnancy with either: (i) 100 mg/day aspirin and 5 mg/day folic acid (group 1); or the same protocol plus 0.4 mg/day enoxaparin (group 2). an age-matched group of triparous women without rm or thrombophilia was used as the control group (group 3).

recurrent miscarriage (rm) is defined as three or more consecutive spontaneous fetal losses and it affects 0.3% to 1% of pregnancies.to investigate the effect of anticoagulant treatment on pregnancy outcomes in patients with previous recurrent miscarriages (rm) who carry a methylenetetrahydrofolate reductase (mthfr) gene mutation. in this longitudinal retrospective study, patients with rm were treated during pregnancy with either: (i) 100 mg/day aspirin and 5 mg/day folic acid (group 1); or the same protocol plus 0.4 mg/day enoxaparin (group 2). an age-matched group of triparous women without rm or thrombophilia was used as the control group (group 3).

Eligibility criteria:
inclusion criteria: * patients with three or more consecutive first-trimester miscarriage * three or more consecutive first-trimester miscatrriages * c677t mthfr gene mutation exclusion criteria: * patients with the a1298c polymorphism

Keywords: recurrent miscarriages aspirin folic acid
frailty in daily practice: screening, consultation and education activities

Conditions: Frailty

Summary: the present study is designed to to estimate the prevalence of frailty and pre-frailty and their associated factors in community-dwelling populations aged 50 years and above in hong kong, and to explore the views of participants taking part in a community health talks or activities on frailty about what the participants felt or had gained from participating, concerns, and suggestions for change or improvement. a survey of 15000 people aged 50 years or older identified in community facilities will be conducted. the participants will be invited to their affiliated centres for a brief screening using the frail scale and assessment. a series of community health talks or activities on frailty will be offered to the participants based on the frailty status.questionnaire and screening tools will be administered by trained researchers.

a 30-month community survey will be conducted, and the survey will be divided into three phases, namely study preparation and subject recruitment (6 months), data collection (18 months), and data entry and analysis (6 months). a survey of 15000 people aged 50 years or older identified in community facilities (e.g., neighbourhood elderly centre, social centre for the elderly) will be conducted. the participants will be invited to their affiliated centres for a brief screening using the frail scale and assessment. a series of community health talks or activities on frailty will be offered to the participants based on the frailty status. questionnaire and screening tools will be administered by trained researchers. the primary outcome will be the prevalence of frailty and pre-frailty. secondary outcomes will cover physical performance measures including hand-grip strength and 5-chair stand test. anthropometric and demographic data will also be collected using standardized methods and questionnaires respectively. views of participants taking part in a community health talks or activities on frailty about what the participants felt or had gained from participating, concerns, and suggestions for change or improvement will be explored by client satisfaction questionnaires.

Eligibility criteria:
inclusion criteria: * people aged 50 years or older * chinese origin * normally reside in hong kong * could speak and understand chinese * willing to follow the study procedures exclusion criteria: -live in a residential aged care facility
feasibility randomized controlled trial using a 'leapfrog' design

Conditions: Anhedonia; Depression

Summary: this study is a small-scale randomized controlled trial (rct) using a 'leapfrog' design (blackwell, woud, margraf, \& schönbrodt, 2019) with the aim of investigating feasibility of this design in the context of an rct of an internet-delivered intervention. the leapfrog design will be applied to a simple cognitive training intervention, imagery cognitive bias modification (imagery cbm), completed over a four-week training period. the trial will start with the three arms described in the initial registration, but these will be removed and new arms added over the course of the trial on the basis of sequential bayesian analyses.


Eligibility criteria:
inclusion criteria: * aged 18 or over * fluent german * willing and able to complete all study procedures (including having a suitable device/ internet access) * interested in monitoring their mood over the study time-period (one month) * score of ≥ 6 on the quick inventory of depressive symptomatology, including ≥ 1 on item 13 (general interest), indicating at least mild levels of depression symptoms and anhedonia exclusion criteria: * no exclusion criteria set

Keywords: cognitive bias modification mental imagery leapfrog design
goal directed fluid therapy in free flap reconstructive surgery

Conditions: Head and Neck Cancer

Summary: wide excision of head and neck cancer with microsurgical free flap's reconstruction (ffr) results to a high cancer cure rate and a good functional recovery. however, this long complex procedure is accompanied with considerable complications. excessive fluid administration during this type of surgery has been connected with poor results. there is growing evidence that goal-directed fluid management (gdfm) might improve the results in high-risk patients. hypothesis: goal directed fluid management will reduce intraoperative fluid volume administered to patients undergoing head and neck reconstructive surgery.


Eligibility criteria:
inclusion criteria: * age 18-80 years * signed informed consent exclusion criteria: * history chf * severe valvular heart defects, intra cardiac shunts * irregular heart rhythm * allergy to hydroxyethyl starch solutions * coagulation abnormalities (inr\>1.5, aptt\>40s, platelet count\<100x10 9/l * history of severe bleeding disorders * renal insufficiency with creatinine \>200umol/l * pregnant of nursing women * history of skin disorders that are accompanied by chronic puritis

Keywords: oncology
phase 1/2 study of zn-d5 for the treatment of relapsed or refractory light chain (al) amyloidosis

Conditions: Amyloidosis; AL Amyloidosis

Summary: this is a single arm, open-label, phase 1/2 study of zn-d5 for the treatment of relapsed or refractory light chain (al) amyloidosis.

a single arm, open-label, phase 1/2 study of zn-d5 for the treatment of relapsed or refractory light chain (al) amyloidosis. the first part of the study is phase 1 dose-escalation and the second part will be phase 2.

Eligibility criteria:
key inclusion criteria: 1. diagnosis of al amyloidosis based on histopathology, the presence of characteristic appearance on electron microscopy, or mass spectrometry typing of amyloid. 2. prior al amyloidosis treatment and has received at least one, but no more than three lines of prior therapy; 3. at least 3 months from hematopoietic stem cell transplantation or the shorter of 60 days or 5 half-lives for biologics, small molecules, or investigational drugs prior to starting treatment; 4. measurable disease defined by serum differential free light chain; 5. assessment of t(11,14) status by fish; 6. eastern cooperative oncology group performance status ≤2 ; 7. history of organ involvement 8. adequate bone marrow function prior to first administration of study drug; 9. adequate organ function; key exclusion criteria: 1. presence of non-al amyloidosis, including wild-type or mutated attr amyloidosis; 2. diagnosis of multiple myeloma according to the 2014 international myeloma working group diagnostic criteria; 3. mayo 2012 stage iv disease; 4. cardiac involvement exclusions apply to some subjects, including heart failure and cardiac arrhythmias. 5. prior treatment with other bcl-2 inhibitors;

Keywords: amyloidosis al amyloidosis rral bcl2 inhibitor t(11;14) zn-d5 light chain amyloidosis light chain (al) amyloidosis
can pelvic floor muscle training reduce my prolapse

Conditions: Pelvic Organ Prolapse

Summary: purpose the aim of this study is to examine if a structured pelvic floor muscle training combined with lifestyle advice with can improve pelvic organ prolapse (pop) symptoms more than structured lifestyle advice programme alone. background pelvic organ prolapse (pop) is a common condition among adult women and almost one in ten women experience symptoms caused by pop. the key symptom of pop is seeing or feeling a bulge in the vaginal opening but pop often gives other symptoms, such as pain, difficulty emptying the bladder or the bowel, incontinence and sexual problems such as dyspareunia. a majority of women with pop will be offered reconstructive surgery but the risk of reoperations is substantial and surgery may cause new symptoms. in one out of four women surgery does not relieve symptoms and the women have been exposed to unnecessary risk of complications. it is therefore important to evaluate the effect of conservative treatments for pop. new studies have shown that pelvic floor muscle training offered in combination with lifestyle advice has a significant on pop symptoms and objective measures of pop compared to a lifestyle advice leaflet alone. no studies have compared the effect of a combined pelvic floor muscle training and lifestyle advice programme with a structured programme of lifestyle advice and hypothetically the structured lifestyle advice programme could have a substantial effect on its own. our hypothesis is that the pelvic floor muscle training is a vital component of a conservative treatment for pop. methods in this single-blind randomised controlled study women with pop will randomised to either a programme of structured pelvic floor muscle training combined with lifestyle advice or a structured lifestyle advice programme alone. both groups will receive the same lifestyle advices through six (separate) lectures within 12 weeks. the training group will be examined and individually instructed in pelvic floor muscle training before the intervention starts and they will, in continuation with their lifestyle lectures, perform pelvic floor muscle training as group training


Eligibility criteria:
inclusion criteria: * ≥18 years of age female reporting bothersome symptoms of any type of pop * newly referred to the hospital clinic * prolapse ≥ii pop-q * understand and write danish exclusion criteria: * instruction in pelvic floor muscle training within the last two years * dementia * pregnancy or less than one year postnatal * disorders that can affect ability to participate in the intervention such as neurological or psychiatric disorders

Keywords: pelvic organ prolapse pelvic floor muscle training prolapse symptoms pelvic organ prolapse quantification system ultrasonography predictors
phase i study of the combination of afatinib and ruxolitinib in patients with treatment-refractory non-small cell lung cancer (nsclc)

Conditions: NSCLC

Summary: this phase ib study will investigate dose limiting toxicity (dlt) and maximum tolerated dose (mtd) of afatinib and ruxolitinib combination therapy, based on the preclinical data that inhibition of il-6r/jak1 signal transmission pathway will increase sensitivity to afatinib.


Eligibility criteria:
inclusion criteria: 1. stage 4 nsclc patients 2. disease progression after platinum doublet (all), egfr tki (if egfr mutant), and crizotinib (if alk positive) 3. men and women aged 20 years or older 4. recovery from previous drug-related toxicity: ctcae 4.03 ≤ grade 1 5. ecog 0 or 1 6. able to orally take and retain drug 7. have a measurable or unmeasurable lesion under recist 1.1 criteria 8. have proper hematological, renal, and hepatic functions 9. intention to use an acceptable contraception 10. able to read and understand the informed consent form exclusion criteria: 1. previous chemotherapy, radiation therapy, immunotherapy, or other anticancer therapy within 14 days 2. clinically significant gastrointestinal disorder or malabsorption syndrome 3. acute digestive disorder 4. major organ failure 5. significant cardiac disorders 6. major operation of a main organ in 4 weeks 7. untreated symptomatic brain metastasis 8. pregnant or nursing 9. previously diagnosed interstitial lung disease(ild) 10. previously treated with irreversible pan-her inhibitor including afatinib or ruxolitinib 11. previously experienced hypersensitivity to an ingredient of the study drug 12. must receive cyp3a4 inducer or inhibitor persistently during the study period. 13. hiv positive or active hepatitis 14. threatening patient's safety is predicted

Keywords: cancer, lung cancer, head and neck squamous cell carcinoma, afatinib, ruxolitinib, egfr, jak, stat
comparison of a novel sling with a traditional abduction sling after shoulder surgery

Conditions: Rotator Cuff Tears; Osteo Arthritis Shoulders

Summary: the objective of this study is to determine if the novel shoulder sling has higher patient satisfaction compared to a traditional, abduction sling with at least equivalent postoperative outcomes after arthroscopic rotator cuff repair and total shoulder arthroplasty.

specific aim i: to determine if patients undergoing arthroscopic rotator cuff repair prefer the traditional abduction sling vs the novel sling. specific aim ii: to determine if patients undergoing total shoulder arthroplasty prefer the traditional abduction sling vs the novel sling. specific aim iii: to determine if short term follow-up (2, 4, 6 weeks), subjective patient-reported outcomes are superior in patients utilizing the novel sling compared to patients utilizing the traditional, abduction sling. specific aim iv: to determine if longer term follow-up (6 weeks, 14 weeks, 6 months, and 12 months), validated patient-reported outcomes are similar (non-inferior) in patients utilizing the novel sling compared to a historical control cohort of patients that only utilized the traditional, abduction sling. the purpose of this aim is to ensure that patients that utilize the novel novel sling for 2 to 4 weeks (with the traditional sling used for the rest of the 6 week period) do not have inferior outcomes compared to patients that have worn the traditional sling for a total of 6 weeks.

Eligibility criteria:
inclusion criteria: * patients undergoing arthroscopic rotator cuff repair and anatomic total shoulder arthroplasty * dominant extremity undergoing surgery exclusion criteria: * patients undergoing revision surgery * patients with a history of significant cervical spine disease, peripheral neuropathy, or concomitant wrist or elbow disorders * patients that do not understand english * patients unwilling to participate or follow up for the study protocols

Keywords: shoulder sling
effect of dietary fiber supplement on the intestinal microbiota among schizophrenia patients

Conditions: Schizophrenia; Central Obesity

Summary: background there has been much interest in the relationship between the types of gut microbiota and the development of obesity in recent years. it has been reported that the proportions of firmicutes and bacteroidetes differ between obese and normal weight human subjects. human intestinal microbiota compositions have been found to be associated with long-term dietary habits and lifestyle. however, an increasing number of researches show that intestinal microbiota composition may be affected after short-term diet intervention. importantly, obesity and metabolic problems play important roles in morbidity and mortality of schizophrenia patients. human intestinal microbiota compositions related with obesity may impact the heath of this population. therefore, we searched current advances about the connection of obesity, intestinal microbiota compositions, and diet in schizophrenia to conduct a clinical research focus on the effect of high fiber diet on the intestinal microbiota of schizophrenia patients with central obesity. method we will investigate in a 4-week intervention whether consumption of dietary fiber supplement(inulin) affect the microbiota composition in schizophrenia inpatients with central obesity. fecal samples from participants before and after the intervention will be processed for the microbiota analysis.


Eligibility criteria:
inclusion criteria: 1. schizophrenia inpatients 2. overweight and with central obesity 3. agree to sign informed consent exclusion criteria: 1. diagnosis of ibs 2. systemic antibiotic use during the past 4 weeks 3. excessive water intake